PRECAUTIONS

Hypersensitivity To Latex

Apnea In Premature Infants

Apnea following intramuscular vaccination has been
observed in some infants born prematurely. Decisions about when to administer
an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely
should be based on consideration of the individual infant's medical status and
the potential benefits and possible risks of vaccination. For RECOMBIVAX HB,
this assessment should include consideration of the mother's hepatitis B antigen status and the high probability of maternal transmission of hepatitis B
virus to infants born to mothers who are HBsAg positive if vaccination is delayed.

Infants Weighing Less Than 2000 g

Hepatitis B vaccination should be delayed until 1 month
of age or hospital discharge in infants weighing < 2000 g if the mother is
documented to be HBsAg negative at the time of the infant's birth. Infants
weighing < 2000 g born to HBsAg positive or HBsAg unknown mothers should
receive vaccine and hepatitis B immune globulin (HBIG) in accordance with ACIP
recommendations if HBsAg status cannot be determined3 [seeDOSAGE
AND ADMINISTRATION].

Prevention And Management Of Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be
available to manage possible anaphylactic reactions following administration [seeCONTRAINDICATIONS].

Limitations Of Vaccine Effectiveness

Hepatitis B virus has a long incubation period.
RECOMBIVAX HB may not prevent hepatitis B infection in individuals who have an
unrecognized hepatitis B infection at the time of vaccination. Additionally, vaccination
with RECOMBIVAX HB may not protect all individuals.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

RECOMBIVAX HB has not been evaluated for its carcinogenic
or mutagenic potential, or its potential to impair fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with
the vaccine. It is also not known whether the vaccine can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. The
vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether the vaccine is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when the vaccine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of RECOMBIVAX HB have been
established in all pediatric age groups. Maternally transferred antibodies do
not interfere with the active immune response to the vaccine. [SeeADVERSE
REACTIONS and Clinical Studies] The safety and effectiveness of RECOMBIVAX
HB Dialysis Formulation in children have not been established.

Geriatric Use

Clinical studies of RECOMBIVAX HB used for licensure did
not include sufficient numbers of subjects 65 years of age and older to
determine whether they respond differently from younger subjects. However, in
later studies it has been shown that a diminished antibody response can be
expected in persons older than 60 years of age.

REFERENCES

3. Centers for Disease Control and Prevention. A
Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus
Infection in the United States. Recommendations of the Advisory Committee on
Immunization Practices (ACIP). Part 2: Immunization of Adults, MMWR 2006, 55(RR-16):
1-25.

Last reviewed on RxList: 9/2/2014
This monograph has been modified to include the generic and brand name in many instances.